Crommelin, Daan J. A. and de Vlieger, Jon S. B. and Weinstein, Vera and Mühlebach, Stefan and Shah, Vinod P. and Schellekens, Huub. (2014) Different pharmaceutical products need similar terminology. The AAPS journal, 16 (1). pp. 11-14.
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Official URL: https://edoc.unibas.ch/72683/
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Abstract
In the last decade, discussions on the development of the regulatory framework of generic versions of complex drugs such as biologicals and non-biological complex drugs have attracted broad attention. The terminology used is far from harmonized and can lead to multiple interpretations of legal texts, reflection papers, and guidance documents regarding market introduction as well as reimbursement. This article describes the meaning of relevant terms in different global regions (Europe, USA, WHO) and offers a proposal for a globally accepted terminology regarding (non-) biological complex drugs.
| Faculties and Departments: | 05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Clinical Pharmacy (Meier) |
|---|---|
| UniBasel Contributors: | Mühlebach, Stefan F |
| Item Type: | Article, refereed |
| Article Subtype: | Research Article |
| Publisher: | American Association of Pharmaceutical Scientists |
| e-ISSN: | 1550-7416 |
| Note: | Publication type according to Uni Basel Research Database: Journal article |
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| Identification Number: |
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| Last Modified: | 20 Aug 2020 12:55 |
| Deposited On: | 20 Aug 2020 12:55 |
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